~IMDS FDA stock with 35 PATENTS DD with links~
Scientific American: IMDS CTML-New Light on Breast Cancer
By Kelli A. Miller Computed tomography laser mammography scan A LARGE AREA of suspicious new blood-vessel growth supporting a cancer tumor is clear in an image made with computed tomography laser mammography (CTLM).
CTLM gives radiologists a colorful 3-D cross-sectional view of each breast. The bright green and white globes conjure the image of a lime Jell-O salad filled with fruit.
"We can look through the breast from the front, the side, the back and all the way through," explains Eric Milne, chief radiologist for Imaging Diagnostic Systems, Inc. The company is currently seeking approval by the U.S. Food and Drug Administration (FDA) as an adjunct to mammography. It plans to eventually push for the technique's use as a screening tool.
The CTLM test, which is expected to cost patients about $150, revealed that Conlan's most recent lump was much larger than x-rays indicated, prompting her doctor to recommend a biopsy.
Cutting Back on Biopsies
Millions of dollars are spent each year on breast biopsies, the majority of which reveal that nothing is wrong. Experts say more informative imaging could dramatically reduce the number of unnecessary procedures.
------------------------------------------------------------------ 1) IMDS, fully reporting OTCQB company http://www.otcmarkets.com/stock/IMDS/company-info 2)
Imaging Diagnostic Systems, Inc. (IDSI) is a development stage medical technology company. The Company is engaged in the development and testing of a Computed Tomography Laser Breast Imaging System for detecting breast cancer (CT Laser Mammography (CTLM).
As of June 30, 2010, IDSI was in the process of commercializing the CTLM in certain international markets where approvals to market have been secured
although CTLM is not yet approved for sale in the United States. The CTLM system is a CT-like scanner, but its energy source is a laser beam and not ionizing x-radiation such as is used in conventional x-ray mammography or CT scanners. IDSI’s Laser Imager for Lab Animals (LILA) program is an optical helical micro-CT scanner in a third-generation configuration. http://www.imds.com/ 3) Watch Video: A Computed Tomography Laser Breast Imaging System for detecting breast cancer (CT Laser Mammography (CTLM). http://www.imds.com/imaging-diagnostics/IDSI-Video.php IMDS link - CT Laser Mammography http://eurolifecare.com/pdf/Product%20Booklet.pdf Another link http://www.edomed.cz/download/ctlm_datasheet.pdf
~~~~~~~~~~ PATENTS, CERTIFICATES, DISTRIBUTORS ~~~~~~~~~~~~~ 4) IMDS has 35 patents, twenty (20) US patents for the various components and technology with an additional fifteen (15) international patents.
http://www.imds.com/ctlm/CTLM-Patents.php http://www.patentstorm.us/search/advanced.html?ptn_no=&inv_nm=&ttl=&isdt_start=&isdt_end=&fldt_start=&fldt_end=&ptn_txt=&asg_nm=Imaging+Diagnostic+Systems%2C+Inc.&atn=&examiner=&cls=&int_cls=&doc_type%5B%5D=0&doc_type%5B%5D=1&sort=0 5) IMDS got ISO-13485 certification
--- CE Marking (accepted 32 countries in Europe)
CE Marking countries list
--- China SFDA certification
--- Canada Medical Device License-CMDCAS
www.imds.com/ctlm/Regulatory-Status.php 6) VITAL FDA LEG: FDA gave export certification to IMDS for enabling sales in international markets. http://www.imds.com/ctlm/Regulatory-Status.php 7) IMDS has distributors in 25 countries http://www.imds.com/ctlm/CTLM-Distributors.php
~~~~~~~~~~~~~~~~~~~ FDA REGULATORY STATUS ~~~~~~~~~~~~~~~~~~~ 7) IMDS- FDA Regulatory Status
As of November 2010, IDSI has submitted a 510(k) application to the FDA.
With this submission, the company moves forward in the process of seeking marketing clearance for its innovative breast imaging device, the CTLM system. The Company intends to pursue a rigorous clinical program to discover and commercialize the envisioned applications. http://www.imds.com/ctlm/Regulatory-Status.php 8) As of Feb 2012, IMDS Securing FDA Approval for DOT
Feb 09, 2012 (Close
-Up Media via COMTEX) --
Imaging Diagnostic Systems, Inc., ("IDSI") a provider of laser based Diffuse Optical Tomography (DOT) for breast cancer detection, announced that it remains fully committed to securing FDA approval.
The company is in the process of submitting a PMA application to the FDA.
Linda Grable, Chairman and CEO of IDSI said "After years
of developing a truly unique and non-invasive breast imaging technology, we are pleased to be recognized as "Diffuse Optical Tomography." In addition, as possibly the first DOT breast imaging modality to seek FDA approval, we are completely dedicated to meeting all of the FDA requirements as quickly as possible.
Mrs. Grable goes on to state that: "IDSI"s management team remains focused on providing shareholder value. Management is presently investigating several long term financing strategies
that will both maintain and increase shareholder value and achieve our FDA objectives
. IDSI understands that there have been some unidentified and uncontrollable forces putting pressure on our stock price.
IDSI is a late stage research and development company that currently has various international registrations and approvals. CTLM (Computed Tomography Laser Mammography) is being used daily by doctors in those markets as a non invasive breast imaging modality. Our ultimate goal is to provide this technology and its benefits to women in the United States.
" Dr. S. Ponder Director
, Advanced Development for IDSI said "We continue to be encouraged by our clinical study results. Especially, when dealing with heterogeneous and extremely dense breasts. We have been able to demonstrate that CTLM increases detection sensitivity especially in Extremely Dense Breast (BIRADS classification), when compared to x-ray based mammography. The CTLM examination is performed without breast compression, x-ray radiation, or contrast injections. In addition, the non-invasive and non-radiation patient benefits of CTLM could become a very important future clinical benefit especially now that many breast screening programs are under significant scrutiny.
((Comments on this story may be sent to email@example.com))
Copyright Close-Up Media, Inc. 2012. All Rights reserved http://www.imds.com/news/ 9) IMDS Clinical Case studies has been made by those hospitals and universities Charite Mitte University Hospital
European Institute of Oncology
Friendship Catholic University
Udine University http://www.imds.com/clinical/CTLM-Case-Studies.php
~~~~~~~~~~~~~~~~~~ IMDS MANAGEMENT TEAM ~~~~~~~~~~~ 10) Linda Grable - Chairman of The Board, CEO & Director
Mrs. Grable is a Founder and significant shareholder of Imaging Diagnostic Systems, Inc.
A graduate of Ohio State University with a BA degree in Journalism and Marketing, she had over 30 years of experience in financial negotiations for both medical and real estate development businesses. In addition, she had over 20 years of executive experience in the medical device industry, for both sales and marketing in the U.S. and foreign countries.
Allan Schwartz - Executive Vice-President, CFO and Co-Founder - Director
Mr. Schwartz joined IDSI in 1994. Mr. Schwartz is the Chief Financial Officer and Executive Vice-President. He has a broad range of management, marketing, engineering, and business development experience. Mr. Schwartz is the developer of the Chronometric Trading System for analyzing stock market trends using neural networks. He also pre-engineered homes for export to Belize, Central America for S.E Enterprises of Miami, Florida. In 1991 he formed Tron Industries, Inc. for the development of low-voltage and self-contained battery powered portable neon products. He is a graduate of C.W. Post College of Long Island University with a B.S. in Business Administration.
Deborah O'Brien - Senior Vice-President
Deborah O'Brien was appointed Senior Vice President on September 15, 2003. Ms. O'Brien joined IDSI in 1995. She has held the positions of Director of Investor Relations, Vice President of Corporate Communications and most recently, since September 2001, Vice President of Business Development. Her responsibilities included developing and executing a strategic corporate communications campaign, managing internal communications and IDSI public relations. Ms. O'Brien developed and established a program of consumer and industry awareness of the CTLM System via a media outreach which targeted industry publications, national network television, radio, nationally-circulated publications and high traffic internet sites.
Ms. O'Brien is responsible for IDSI's FDA process including clinical data collection, preparation, filings, and interface with the FDA. Prior to joining IDSI, she worked for seven years in the financial arena, managing investor accounts, and in the medical device industry, marketing medical equipment. Ms. O'Brien began her career in the mortgage loan industry as an account executive with Citibank.
David Schmidt – Director
On August 1, 2011, Mr. Schmidt was appointed by our Board of Directors to serve on the Board. Mr. Schmidt has served since 2008 as an independent consultant advising companies in the chemicals and materials, healthcare, and alternate energy industries regarding strategic marketing and execution services. From 2004 until 2008, Mr. Schmidt served as the Manager of Commercial Excellence and the Strategic Marketing and Business Development Manager at Honeywell International, Inc., Morristown, NJ. From 2000 until 2003, Mr. Schmidt served as a Senior Director and Chief Operations Officer of Plasmion Corporation, Inc., Hoboken, NJ. Mr. Schmidt has also served in management and officer positions at Film Specialties, Inc., Hillsborough, NJ, from 1993 until 2000; at Hydromer, Inc., Whitehouse, NJ, an invasive medical device specialty coatings company from 1989 until 1992; and at ROI Group, Inc., Parsippany, NJ, from 1986 until 1988. Mr. Schmidt earned his bachelor of science in business and economics from Lehigh University.
CFO Michael W. Addley, started in Jan 2012
Mr. Addley is an executive with decades of experience leading domestic and international medical device operations. The Company believes that his extensive experience launching "high-tech" medical devices and new procedures will play a valuable role in the Company's efforts to pursue FDA marketing clearance. Most recently, from 2006 - 2008, Mr. Addley served as Vice-President/New Business Development of Polar Technics Ltd. (Australia), and since 2008 has provided consulting services to medical device manufacturers, including the Company, through his consulting firm, Addley International Corp., London, Ontario.
Dr. Jose Cisneros, Head of Clinical Research for IMDS-
Imaging Diagnostic Systems, has been invited to present; “New Imaging Modalities for Breast Cancer” featuring CT Laser Breast Imaging (CTLM). Dr Cisneros is a radiologist and biomedical engineer, with more than 30 years of clinical investigate and preparation in healthcare technology. His area of skill is in Biomedical Imaging, Digital imaging systems, evidence Ultrasound and Magnetic Resonance Imaging. He was a highbrow at the Jefferson Ultrasound Research and Education Institute in Philadelphia and previous to fasten IDSI he worked as a clinical operative for Picker International Inc.
11) IMDS has 18 employees
~~~~~~~~~~~ REVENUE, SHARE STRUCTURE ~~~~~~~~~~
12) IMDS revenue increased 480% in the first quarter of 2012 when you compare first quarter of 2011.
2012(first quarter): 211,720 dollars
2011(first quarter): 36,515 dollars
13) IMDS O/S 2.4 billion, a/s 4 billion
14) The company requested SEC to Cancel 740 million shares recently
SEC FILINGS OUT ON MAY 17, 2012
15) IMDS- insiders hold 52 million of Outstanding shares
Name and Address of Beneficial Owner
Number of Shares of Common Stock Owned Beneficially(1)(2)
% of Outstanding Shares of Common Stock
Number of Shares of Series Q Preferred Owned
% of Outstanding Series Q Preferred Stock
Linda B. Grable
5307 NW 35th Terrace
Fort Lauderdale, FL 33309
Allan L. Schwartz
5307 NW 35th Terrace
Fort Lauderdale, FL 33309
5307 NW 35th Terrace
Fort Lauderdale, FL 33309
5307 NW 35th Terrace
Fort Lauderdale, FL 33309
All officers and directors
as a group (4 persons)
~~~~~~~~~~~ MOST RECENT NEWS, PUBLICATIONS ~~~~~~~~~~~~~~
16) IMDS'S giant Distributor JAPAN Shimadzu
Imaging Diagnostic Signs Shimadzu Medical to Market Its CTLM(R) Laser Breast Imaging Device in Australia, New Zealand and the Pacific Islands
FORT LAUDERDALE, FL, May 14, 2012 (MARKETWIRE via COMTEX) -- Imaging Diagnostic Systems, Inc. (OTCBB: IMDS), a pioneer in laser breast imaging, announced today that it has signed a distribution agreement with Shimadzu Medical to market and sell its Computed Tomography Laser Mammography (CTLM(R)) System in Australia, New Zealand and the Pacific Islands.
"This strategic move follows in line with our vision to be in the forefront of innovative technologies that will further enhance our business. The Directors of Shimadzu Corporation unanimously agreed that the CTLM(R) system could heighten our image in the breast imaging realm. IDSI has developed a high quality innovative breast imaging product that will expand our product range. Shimadzu is well positioned to provide ongoing sales, service and support for the CTLM given our history and expertise in the medical device arena. We are excited to make this innovative technology available to women in Australia, New Zealand and the Pacific Islands," commented Nick Mascoulis, General Manager/Shimadzu Medical Systems (Oceania) P/L.
Shimadzu Medical Systems (Oceania) Pty Ltd is an Australasian subsidiary of Shimadzu Corporation, Kyoto, Japan. Shimadzu's goal is to support a healthy, comfortable living for all people. They have strived to contribute to people's health and well-being since their inception in 1875. Shimadzu focuses on the development of "molecular imaging technology" to enable detection of subtle symptoms before the onset of full-blown diseases.
Linda Grable, CEO of Imaging Diagnostic Systems, Inc., states, "IDSI is very excited to appoint Shimadzu Corporation, a leader of global technologies, as the distributor in Australia, New Zealand and the Pacific Islands. We are eager to work with Shimadzu to make CTLM(R) available to women in that part of the globe."
17) MAREEN GROUP KUWAIT DISTRIBUTOR
FORT LAUDERDALE, FL, May 22, 2012 (MARKETWIRE via COMTEX) -- Imaging Diagnostic Systems, Inc. IMDS 0.00% , a pioneer in laser breast imaging, announced today that it has signed a distribution agreement with Mareen Group to market and sell its Computed Tomography Laser Mammography (CTLM(R)) System in Kuwait.
"Mareen Group is honored to present the CTLM(R) to the women of Kuwait. We are eager to support the imaging needs of patients through this dignified and innovative laser breast imaging modality," commented Ahmad Abdulrahman, General Manager of Mareen Group.
Mareen Group is a Medical & Pharmaceutical distribution company well established and based in Kuwait. They have been in operation since 1998, proudly providing various medical and healthcare institutions within Kuwait and the surrounding areas with advanced medical equipment and pharmaceuticals from across the globe. The philosophy of Mareen Group has always been to build close ties with their customers by supporting their every need with prompt professional service and support.
Imaging Diagnostic's CEO, Linda Grable, states, "IDSI is delighted to assign Mareen Group, a well established medical company in Kuwait, as our new distributor. The women in Kuwait will hopefully benefit from CTLM(R)'s unique and discrete breast imaging process to aid in the diagnosis and management of breast abnormalities. We are enthusiastic to work with Mareen Group to make the CTLM(R), a non-invasive alternative, accessible to women in Kuwait."
~~~Hundreds of thousands of Hospitals and Clinics in the world. Almost all of them are potential customers of IMDS.
~~~~ With FDA update PENNYLAND, with FDA approval DOLLARLAND, IMO.
~~~ IMDS is an sleeping giant, undervalued solid company, Read, check the links..make your own decision
~Blue~ 20 CTLM sales agreement, $9$ million REVENUE
RECENT 10Q, March 31, 2012
In December 2011, we announced that we signed an exclusive distribution agreement with ID Matrix Systems to market and sell our CTLM® systems to private and government hospitals and private imaging centers throughout China and Hong Kong.
The agreement stipulates that ID Matrix must purchase a minimum of 15 CTLM® systems within the first year of the contract along with a 50% deposit with each order to remain our exclusive distributor for the territories.
RECENT 10Q PAGE 66
+++++++++++++++ ADD THIS +++++++++++++++++++
First of Five Systems sold to Mexico
First of Five Systems to Be Installed
Wednesday, November 23rd, 2011
FORT LAUDERDALE, Fla., November 3, 2011–(BUSINESS WIRE)– Imaging Diagnostic Systems, Inc., (OTCBB:IMDS.OB – News), a pioneer in laser optical breast imaging announced today that it has sold the first system of five ordered to be installed in Mexico. The system is scheduled to be installed during the third week of December. The purchase order was made through its exclusive distributor Kepter Internacional for Estados Unidos Mexicanos.
Kepter Internacional is scheduled to hold a presentation featuring the CTLM system and announcing its arrival to Mexico in January in front of the COFEPRIS (Health Ministry) of Mexico. Kepter Internacional is the exclusive agent for Imaging Diagnostic Systems, authorized to promote, distribute and service the CT Laser Mammography (CTLM) System throughout Mexico.
TOTAL 20 CTLM sales agreement
IMDS MARKETING DIRECTOR RICHARD GRABLE SAYS CTLM PRICE 495,000 DOLLARS, confirmed many times.
The company Phone: 954-581-9800 easy to confirm. call him
LETS DO THE MATH:
20 CTLM x 495,000 DOLLARS EACH= 9.9 MILLION DOLLARS..
HERE IS THE SOURCE OF MONEY.